Clinical, Instrumental and Histological Evaluation of the Combined Use of Onabotulinumtoxin A and Hyaluronic Acid Fillers in Patients With Facial Paralysis
试验速览
- 阶段
- 2 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- House-Brackmann scale
研究概览
简要总结
Social interaction via facial mimic expression is crucial in human relationship and communication. Neural function disorder in this mechanism therefore affects human communication and social interaction. Facial nerve palsy is the paralysis of any structure innervated by the facial nerve, thus inibiting and severely compromising facial expression. In the last decade a new algorithm of treatment of facial paralysis has been raised. It connects the expertise of Aesthetic Medicine with the expertise of Plastic and Reconstructive Surgery. It is based on the use of Botulinum Toxin (BT) and Hyaluronic Acid (HA fillers). Botulinum toxin is a paralytic toxin that determine flaccid paralysis and is nowadays used in the static correction of facial paralysis with minimal invasiveness, optimal results and no time consumption. The HA fillers has the ability to restore facial volume loss and it is used in the treatment of facial palsy to harmonize symmetry. The aim is to study the effects of the BT and HA in facial paralysis patients in order to understand the efficacy of these products that have never been injected together in this type of patients. Primary objective. To evaluate the functional improvement of facial asymmetries due to facial nerve lesion after the treatment with OnabotulinumtoxinA and hyaluronic acid fillers compared with the untreated group. The evaluation will be performed analyzing the two groups at the baseline (visit 0) and the end of the treatment period (visit 5, after 9 months). Improvement difference of at least 1 grade on the House-Brackmann scale, compared with the untreated group, will be considered clinically significant. Methods. The investigation is randomized open lab phase II single centre clinical trial. This experimental study proposes to evaluate a group of 70 patients affected by hemifacial paralysis of level 3 to 6 on the House-Brackmann scale. 35 patients will be treated (Group A) with both OnabotulinumtoxinA and hyaluronic acid fillers with a monitored follow up. A control group of 35 patients (Group B) who will not be treated, will be enrolled to compare the efficacy of the treatment. During the study all the AE/ADR will be recorded.
详细描述
The patients will be evaluated with instrumental (3D pictures, neuro-physiological examination (EMG), radiological [Magnetic Resonance Imaging (MRI)], Cone Beam Computer Tomography (CBCT) and Ultrasound (US)) and non-instrumental analysis (clinical questionnaires and hystological analysis). The histology will be performed with both traditional and electronic approaches. The area of the biopsy will be the paralytic area in the two groups in order to study the soft tissue modulation of the injected molecules. Patient's qiality of life (QoL), through specifically test (FACE-Q), will be also evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged > 18 years and < 65 years
- •Hemifacial paralysis from 3 to 6 on the House-Brackmann scale
- •Never treated with HA and BTX injection
- •Signed informed consent
- •Women of childbearing potential will only be included in the study if uptaking hightly effective birth control measures.
排除标准
- •Hypersensitivity to any component of the products used
- •Diabetes, systemic disease, coronary artery disease, acute-chronic hepatitis C, autoimmune disease and/or other disease involving poor general health clotting problem. Peripheric neuro-musculars disorders, amyotrophic lateral sclerosis.
- •Pregnant or lactating
研究组 & 干预措施
Hyaluronic Acid filler and Botulinum Toxin group
- Hyaluronic Acid filler:
- Juvederm Volbella: it will be used in the softer soft tissue, beacuse its reology is the softest
- Juvederm Volift: it will be used in malar area, because its reology is intermediate between the three products
- Juvederm Voluma: il will be used unstructured area bacause it has the best rheologic characteristics in the reintegration of loss of tissue.
The differents products are going to use in different areas, depending on the area of the paralysis. 2. Botulinum Toxin:
- Vistabex (50U/vial): it is going to be used in the controlateral area of the paralysed face, in order to relax muscle hyper-tonicity.
Dosage and administration steps will be selected according to the clinical situation.
干预措施: Juvederm (Device)
Hyaluronic Acid filler and Botulinum Toxin group
- Hyaluronic Acid filler:
- Juvederm Volbella: it will be used in the softer soft tissue, beacuse its reology is the softest
- Juvederm Volift: it will be used in malar area, because its reology is intermediate between the three products
- Juvederm Voluma: il will be used unstructured area bacause it has the best rheologic characteristics in the reintegration of loss of tissue.
The differents products are going to use in different areas, depending on the area of the paralysis. 2. Botulinum Toxin:
- Vistabex (50U/vial): it is going to be used in the controlateral area of the paralysed face, in order to relax muscle hyper-tonicity.
Dosage and administration steps will be selected according to the clinical situation.
干预措施: Vistabex (Drug)
结局指标
主要结局
House-Brackmann scale
时间窗: Day 0 and day 270
Change from baseline House-Brackmann score at day 270 will be assessed and then compared between the trial groups. The House-Brackmann score is a score to grade the degree of nerve damage in a facial nerve palsy. The measurement is determined by measuring the upwards (superior) movement of the mid-portion of the top of the eyebrow, and the outwards (lateral) movement of the angle of the mouth. Ti is consist of VI level: Grade I - Normal; Grade II - Slight Dysfunction; Grade III - Moderate Dysfunction; Grade IV - Moderate Severe Dysfunction; Grade V - Severe Dysfunction; Grade VI - Total Paralysis
次要结局
- Facial aesthetic(Day 0 and day 270)
- Facial aesthetic - thickness of hard tissue(Day 0 and day 270)
- Facial Appearance(Day 0 and day 270.)
- Health-Related Quality of Life(Day 0 and day 270)
- Adverse Effects(Day 0 and day 270)
- Facial symmetry(Day 0, day 20, day 150, day 270)
- Facial aesthetic - tropism of muscles(Day 0 and day 270)
- Patients experience of care(Day 0 and day 270)
- Adverse Events(Day 0, day 20, day 30, day 140, day 150, day 270)
- Facial aesthetic - thickness of soft tissue(Day 0 and day 270)
- EMG(Day 0 and day 270)
- Hystological analysis(Day 0 and day 270)
- Facial aesthetic - patho-physiological condition(Day 0 and day 270)
研究者
Dario Bertossi
Prof., Department of Chirurgia Maxillo-Facciale and Odontostomatologia
Azienda Ospedaliera Universitaria Integrata Verona